deltatrials
Terminated PHASE2 INTERVENTIONAL 8-arm NCT03341962

Phase 2 Dose-finding IMU-838 for Ulcerative Colitis (CALDOSE-1)

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-finding Study to Evaluate the Efficacy and Safety of IMU-838 for Induction and Maintenance Therapy in Moderate-to-severe Ulcerative Colitis

Sponsor: Immunic AG

Interventions IMU-838 Placebo
Updated 22 times since 2017 Last updated: Feb 6, 2024 Started: Mar 15, 2018 Primary completion: Nov 16, 2022 Completion: Nov 16, 2022
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Considering the efficacy results of the induction phase (allowed use of corticosteroids as concomitant medication) in the study population and since IMU-838 did not show superiority over placebo, the OLE was prematurely closed by the sponsor.

Other terminated trials from Immunic AG

More terminations from Immunic AG

A PHASE2 clinical study on Ulcerative Colitis, this trial is terminated or withdrawn. The trial is conducted by Immunic AG and has accumulated 22 data snapshots since 2018. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

~Dec 2017 – ~Apr 2018 · 4 months · monthly snapshot~Apr 2018 – ~Jun 2018 · 2 months · monthly snapshot~Jun 2018 – ~Apr 2019 · 10 months · monthly snapshot~Apr 2019 – ~Feb 2020 · 10 months · monthly snapshot~Feb 2020 – ~Mar 2020 · 29 days · monthly snapshot~Mar 2020 – ~Aug 2020 · 5 months · monthly snapshot~Aug 2020 – ~Jan 2021 · 5 months · monthly snapshot~Jan 2021 – ~Feb 2021 · 31 days · monthly snapshot~Feb 2021 – ~Mar 2021 · 28 days · monthly snapshot~Mar 2021 – ~Apr 2021 · 31 days · monthly snapshot~Apr 2021 – ~May 2021 · 30 days · monthly snapshot~May 2021 – ~Jun 2021 · 31 days · monthly snapshot~Jun 2021 – ~Sep 2021 · 3 months · monthly snapshot~Sep 2021 – ~Nov 2021 · 2 months · monthly snapshot~Nov 2021 – ~May 2022 · 6 months · monthly snapshot~May 2022 – ~Nov 2022 · 6 months · monthly snapshot~Nov 2022 – ~Mar 2023 · 4 months · monthly snapshot~Mar 2023 – ~Apr 2024 · 13 months · monthly snapshot~Apr 2024 – ~Jul 2024 · 3 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – present · 10 months · monthly snapshot

Change History

22 versions recorded
  1. Sep 2025 — Present [monthly]

    Terminated PHASE2

  2. Sep 2024 — Sep 2025 [monthly]

    Terminated PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE2

  4. Apr 2024 — Jul 2024 [monthly]

    Terminated PHASE2

    Status: Active Not RecruitingTerminated

  5. Mar 2023 — Apr 2024 [monthly]

    Active Not Recruiting PHASE2

Show 17 earlier versions
  1. Nov 2022 — Mar 2023 [monthly]

    Active Not Recruiting PHASE2

  2. May 2022 — Nov 2022 [monthly]

    Active Not Recruiting PHASE2

  3. Nov 2021 — May 2022 [monthly]

    Active Not Recruiting PHASE2

    Status: RecruitingActive Not Recruiting

  4. Sep 2021 — Nov 2021 [monthly]

    Recruiting PHASE2

  5. Jun 2021 — Sep 2021 [monthly]

    Recruiting PHASE2

  6. May 2021 — Jun 2021 [monthly]

    Recruiting PHASE2

  7. Apr 2021 — May 2021 [monthly]

    Recruiting PHASE2

  8. Mar 2021 — Apr 2021 [monthly]

    Recruiting PHASE2

  9. Feb 2021 — Mar 2021 [monthly]

    Recruiting PHASE2

  10. Jan 2021 — Feb 2021 [monthly]

    Recruiting PHASE2

  11. Aug 2020 — Jan 2021 [monthly]

    Recruiting PHASE2

  12. Mar 2020 — Aug 2020 [monthly]

    Recruiting PHASE2

  13. Feb 2020 — Mar 2020 [monthly]

    Recruiting PHASE2

  14. Apr 2019 — Feb 2020 [monthly]

    Recruiting PHASE2

  15. Jun 2018 — Apr 2019 [monthly]

    Recruiting PHASE2

  16. Apr 2018 — Jun 2018 [monthly]

    Recruiting PHASE2

    Status: Not Yet RecruitingRecruiting

  17. Dec 2017 — Apr 2018 [monthly]

    Not Yet Recruiting PHASE2

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Immunic AG
Data source: Immunic AG

For direct contact, visit the study record on ClinicalTrials.gov .